1. Field of the Invention
The present invention relates in general to locking mechanisms for containers for sterilization and storing articles, and more particularly to a disposable tamper evident security device for providing an indication of whether the container has been opened subsequent to sterilization.
2. Description of the Prior Art
Sterilization container systems have been developed to facilitate the storage of sterilized articles in a manner such that their sterilized state is maintained during storage. These container systems permit entry of the sterilizing medium into the container during the performance of the sterilization process, but prevent the entry of contaminating organisms into the containers.
Sterilization containers which contain articles which have been sterilized are commonly left unattended for relatively long periods of time before the articles are used. During this storage period the possibility exists that the container will be opened, causing contamination of the articles, and then subsequently reclosed. Such an event is not readily visible. Most medical instrument sterilization containers employ some form of security device to give evidence of sterile integrity prior to use. Closures for sterilization containers are often provided with seals which must be destroyed to enable opening of the locking mechanism for the container. It is also known to use so-called indicator adhesive tapes as seals, i.e. tapes which change their color during sterilization. The locking mechanism of such sterilizing containers can only be opened by destroying such an indicator tape.
U.S. Pat. No. 4,820,499 describes a device and a means for securing a paper data card which also indicates by a punched hole that the sterilizing container has been opened. Devices described in U.S. Pat. Nos. 4,562,047 and 4,915,913 are fabricated of plastic and designed to be fractured when the container is opened and provide a permanent indication of the incident. These devices are also provided with means for indicating that the container has been exposed to a sterilization process.
All known "tamper evident" devices require additional elements to: (1) automatically indicate whether the container has been sterilized and (2) indicia fields for inscribing data. Many of the current "tamper evident" devices are fabricated of high temperature resistant injection moldable plastic resins. These resins are expensive and consume non-renewable resources (oil), are non-biodegradable and when incinerated, burn with high temperatures and emit toxic gases which are known to pollute the atmosphere.
An object of the present invention is to provide a "tamper evident" device which integrates the various discrete elements, i.e. locking function, sterilization indicator and data elements into a single disposable device.
Another object of the present invention is to provide a tamper evident locking device that reduces the impact on the waste disposal systems in health care facilities and land fills, while reducing or eliminating the production of toxic by-products resulting from incineration.
A further objective of the present invention is to provide an inexpensive disposable "tamper evident" locking device having simple, yet functionally effective design features.